Evidence map›Paper›PMID 24431895›Full record

Trial reportWorld journal of gastroenterology2013

Efficacy of switching to telbivudine plus adefovir in suboptimal responders to lamivudine plus adefovir.

Hana Park, Jun Yong Park, Seung Up Kim, Do Young Kim, Kwang-Hyub Han, Chae Yoon Chon, Sang Hoon Ahn

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in World journal of gastroenterology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Guideline
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Hana ParkHana Park, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam-si 463-712, South Korea.
Jun Yong ParkHana Park, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam-si 463-712, South Korea.
Seung Up KimHana Park, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam-si 463-712, South Korea.
Do Young KimHana Park, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam-si 463-712, South Korea.
Kwang-Hyub HanHana Park, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam-si 463-712, South Korea.
Chae Yoon ChonHana Park, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam-si 463-712, South Korea.
Sang Hoon AhnHana Park, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam-si 463-712, South Korea.
CHA University Bundang Medical Center · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo examine the efficacy of telbivudine (LdT) + adefovir (ADV) vs continuation of lamivudine (LAM) + ADV in patients with LAM-resistant chronic hepatitis B (CHB) who show a suboptimal response to LAM + ADV.

methodsThis was a randomized, active-control, open-label, single-center, parallel trial. All eligible patients were enrolled in this study in Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea, between March 2010 and March 2011. Hepatitis Be antigen (HBeAg)-positive CHB patients whose serum hepatitis B virus (HBV) DNA remained detectable despite at least 6 mo of LAM + ADV therapy were included. Enrolled patients were randomized to either switching to LdT (600 mg/d orally) plus ADV (10 mg/d orally) (LdT + ADV group) or to continuation with LAM (100 mg/d orally) plus ADV (10 mg/d orally) (LAM + ADV group), and were followed for 48 wk. One hundred and six patients completed the 48-wk treatment period. Serum HBV DNA, HBeAg status, liver biochemistry and safety were monitored at baseline and week 12, 24, 36 and 48.

resultsThe duration of prior LAM + ADV treatment was 18.3 (LdT + ADV) and 14.9 mo (LAM + ADV), respectively (P = 0.131). No difference was seen in baseline serum HBV DNA between the two groups [3.66 (LdT + ADV) vs 3.76 (LAM + ADV) log10 IU/mL, P = 0.729]. At week 48, although there was no significant difference in the mean reduction of serum HBV DNA from baseline between LdT + ADV group and LAM + ADV group (-0.81 vs -0.47 log10 IU/mL, P = 0.167), more patients in the LdT + ADV group had undetectable HBV DNA levels compared to those in the LAM + ADV group (30.2% vs 11.5%, P = 0.019). Three patients with LdT + ADV treatment and 2 patients with LAM + ADV treatment achieved HBeAg loss. The patients in both groups tolerated the treatment well without serious adverse events. The proportion of patients with estimated glomerular filtration rate ≥ 90 mL/min per 1.73 m(2) in the LdT + ADV group increased from 49.1% (26/53) at baseline to 58.5% (31/53) at week 48, while that in the LAM + ADV group decreased from 37.7% (20/53) at baseline to 30.2% (16/53) at week 48.

conclusionThe switch to LdT + ADV in suboptimal responders to LAM + ADV showed a significantly higher rate of virologic response at week 48. These results suggest that LdT + ADV could be a therapeutic option for patients who are unable to use enofovir disoproxil fumarate for any reason.

Indexed as

Drug Resistance, ViralDrug SubstitutionAdenineAdministration, OralAdultAgedAntiviral AgentsBiomarkersDNA, ViralDrug Administration ScheduleDrug Therapy, CombinationFemaleHepatitis B, ChronicHepatitis B e AntigensHepatitis B virusHumansadefovirAdenineAntiviral AgentsBiomarkersDNA, ViralHepatitis B e AntigensLamivudineOrganophosphonatesTelbivudineThymidineAntiviral resistanceChronic hepatitis BLamivudineSuboptimal responseTelbivudine

Identifiers

PMID24431895
PMCPMC3837266
OpenAlexW1995841201

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.